Last reviewed 2026-04-20 · How we verify

Banaba Leaf Extract

Deraya University · Phase 1 active Small molecule Quality 0/100

Banaba Leaf Extract is a Small molecule drug developed by Deraya University. It is currently in Phase 1 development. Also known as: moringa banna nigella.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Banaba Leaf Extract
Also known as	moringa banna nigella
Sponsor	Deraya University
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Banaba Leaf Extract CI brief — competitive landscape report
Banaba Leaf Extract updates RSS · CI watch RSS
Deraya University portfolio CI

Frequently asked questions about Banaba Leaf Extract

What is Banaba Leaf Extract?

Banaba Leaf Extract is a Small molecule drug developed by Deraya University.

Who makes Banaba Leaf Extract?

Banaba Leaf Extract is developed by Deraya University (see full Deraya University pipeline at /company/deraya-university).

Is Banaba Leaf Extract also known as anything else?

Banaba Leaf Extract is also known as moringa banna nigella.

What development phase is Banaba Leaf Extract in?

Banaba Leaf Extract is in Phase 1.

Manufacturer: Deraya University — full pipeline
Also known as: moringa banna nigella

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing